The field of endovascular surgery is rapidly becoming an alternative to more traditional surgeries such as carotid endarterectomy, coronary artery bypass grafting, aortic aneurysm repair, and vascular grafting. Percutaneous intervention is becoming the primary means for revascularization in many such procedures. Distal embolization of friable debris from within the diseased conduit remains a risk of endovascular surgery, potentially involving complications such as myocardial infarction and ischemia. Devices such as balloon catheters and embolic filters have been used to control and remove embolic debris dislodged from arterial walls during endovascular procedures, distal to an interventional procedure site. Percutaneous introduction of these devices typically involves access via the femoral artery lumen of the patient's groin vasculature. An introducer sheath may then be inserted in the wound, followed by a guide catheter that is advanced to the site to be treated. A guidewire is usually introduced into the lumen of the vasculature and advanced distally, via manipulation by the clinician, to cross the lesion or area of treatment. Then a catheter containing the device(s) may be employed to traverse the length of the guidewire to the desired deployment location. Once the distal protection device is deployed, the lesion or stenosis is available for treatment.
A common practice for treating the lesion or stenosis is to deploy a stent at the target location to increase the lumen size of the vessel and maintain or increase patency. When feeding a guidewire through the lumen of a stent, there is a possibility that the tip of the wire will become diverted and/or ensnared by the stent. This possibility increases with increasing vessel tortuosity. This problem has been addressed through the use of a soft, flexible, floppy tip at the distal end of the wire to improve steerability and reduce the possibility of engaging the stent or peripheral vasculature. However, a flat-tipped catheter advanced over a guidewire with an inside diameter larger than the outside diameter of the guidewire, presents a sharp edge to the vessel or stent at the point of tangential contact. The exposure of this edge increases with vessel tortuosity and with an increase in differences between the guidewire outside diameter and catheter inside diameter.
Embolic filters and balloons are often deployed by traversing the lesion being treated and deploying the device distally. If a balloon wire or embolic filter becomes caught in the patient's vasculature or is otherwise prevented from removal by a stent, such as the device becoming entrapped within the struts of a stent, then the clinician is typically required to perform higher risk procedures to retrieve them. These include subjecting the device to greater retrieval forces, and removal through invasive surgical techniques. The former increases the risk of the device becoming detached from its guidewire or catheter, whereas the latter exposes the patient to the increased risks of open surgical extraction. Successful retrieval of these devices in situations other than those originally anticipated, without intimal dissection, plaque, hemorrhage, or vessel occlusion, is an important advancement in the field of interventional endovascular surgery.